MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3 100CM; CATHETER, PERCUTANEOUS

Model Number	5626XX
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/1982
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6f.070¿ 100cm extra back-up 3 (xb3) vista brite tip guiding catheter linked in patient and got stuck.Vascular surgeon had to intervene and the device was removed the type of procedure preformed was a cardiac percutaneous coronary procedure.The access site was radial.The device was prepped per the instruction for use (ifu).Other devices used during the procedure did not kink or bend with the product at any time.The device will not be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly g4, g6, h1, h2, h3 and h6.As reported, a 6f.070¿ 100cm extra back-up 3 (xb3) vista brite tip guiding catheter kinked in the patient and got stuck.Vascular surgeon had to intervene and the device was removed.The type of procedure performed was a cardiac percutaneous coronary procedure.The access site was radial.The device was prepped per the instructions for use (ifu).Other devices used during the procedure did not kink or bend with the product at any time.The device was not returned for analysis.Additionally, as the sterile lot number was not available, product history record (phr) reviews could not be performed.Based on the information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device for analysis, the reported customer event ¿catheter (body/shaft) - withdrawal difficulty¿ and ¿catheter (body/shaft) - kinked/bent - in-patient¿ could not be confirmed and the exact root cause could not be determined.Procedural/handling factors may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, ¿inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.If strong resistance is met during manipulation, discontinue the procedure and determine the cause of the resistance before proceeding.If the cause of the resistance can not be determined, withdraw the catheter.Torquing the guiding catheter excessively while kinked may cause damage which could result in possible separation along the catheter shaft.Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire and catheter sheath introducer).Advancement, manipulation and withdrawal of the guiding catheter should always be performed under fluoroscopic guidance.Extreme care must be taken to avoid damage to the vasculature through which the guiding catheter passes.¿ without a lot number to conduct a phr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: 6F .070 XB 3 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11381710
• Report Number: 9616099-2021-04297
• Device Sequence Number: 16977908
• Product Code: DQY
• UDI-Device Identifier: 20705032020142
• UDI-Public: 20705032020142
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5626XX
• Device Catalogue Number: 5626XX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1